Apparatus and methods for treating obstructions within body lumens

• US 9,757,137 B2
• Filed: 07/20/2015
• Issued: 09/12/2017
• Est. Priority Date: 02/18/2009
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Hotspur Technologies, Inc. (Teleflex Incorporated)
• Inventors: Krolik, Jeffrey A., Domingo, Juan, Watanabe, Gwendolyn, Betelia, Ray, Fernandez, Lucas
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US14/803,112
• Publication Number:
  US 20150320983A1
• Time in Patent Office: 785 Days
• Field of Search: 604 9901- 9904, 606159, 606192-197
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 : Valves
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Claims

1. A method for treating a body lumen using a balloon apparatus, the method comprising:

receiving the balloon apparatus, comprising;

an outer member including a first lumen extending between proximal and distal ends thereof,

an inner member slidable within the first lumen, the inner member having a proximal end and a distal end, and comprising a second lumen extending between the proximal and distal ends thereof, and

a sealing member on the distal end of the inner member, and

a balloon comprising a proximal end attached to the distal end of the outer member, a distal end including an outlet and an interior communicating with the first lumen and the outlet;

introducing the distal end of the outer member into the body lumen with the balloon in a contracted condition while the inner member is in a first, distal position such that the outlet is substantially sealed by the sealing member, the balloon is slightly stretched by axial force applied by the sealing member, and at least a portion of the sealing member extends distally beyond the outlet to provide an atraumatic tip;

advancing the second lumen of the inner member over a guidewire in the body lumen to advance the balloon apparatus within the body lumen;

directing an actuator on a proximal end of the balloon apparatus to move the inner member to a second, proximal position consequently directing the sealing member away from the outlet to open the outlet;

delivering a first fluid through the first lumen such that the first fluid passes through the interior of the balloon and exits the open outlet into the body lumen;

directing the inner member towards the first, distal position to substantially seal the outlet with the sealing member; and

delivering a second fluid through the first lumen with the outlet substantially sealed, thereby expanding the balloon from the contracted condition to an enlarged condition, while the inner member is in the first, distal position.

2. The method of claim 1, further comprising:

directing the balloon to an expanded helical shape within the body lumen; and

directing the balloon along a wall of the body lumen in the expanded helical shape to remove material from the wall of the body lumen.

3. The method of claim 1, further comprising dilating a lesion within the body lumen while the balloon is in the enlarged condition.

4. The method of claim 1, wherein expanding the balloon from the contracted condition to the enlarged condition comprises expanding a prosthesis carried on the balloon.

5. The method of claim 4, wherein the prosthesis comprises at least one of a stent, a stent-graft, and a prosthetic valve.

6. The method of claim 1, wherein expanding the balloon from the contracted condition to the enlarged condition comprises expanding the balloon until the balloon contacts a wall of the body lumen, the method further comprising delivering energy via the balloon to tissue adjacent the wall of the body lumen.

7. The method of claim 1, wherein expanding the balloon from the contracted condition to the enlarged condition comprises expanding the balloon until the balloon contacts a wall of the body lumen, thereby delivering one or more agents carried by the balloon to tissue adjacent the wall of the body lumen.

8. The method of claim 1, wherein the balloon further comprises a carrier comprising one or more diagnostic or therapeutic agents, and wherein expanding the balloon from the contracted condition to the enlarged condition comprises expanding the carrier.

9. The method of claim 1, further comprising:

directing the inner member to a position between the first, distal position and the second, proximal position such that the sealing member partially obstructs the outlet; and

delivering the second fluid through the first lumen such that some of the second fluid exits the outlet into the body lumen and some of the second fluid is delivered into the interior of the balloon to partially expand the balloon within the body lumen.

10. The method of claim 1, wherein the first fluid comprises a contrast agent, the method further comprising:

imaging the body lumen using external imaging that is enhanced by the contrast agent; and

manipulating the distal end of the outer member within the body lumen based at least in part on the external imaging.

11. The method of claim 1, wherein the second fluid is different from first fluid.

12. The method of claim 1, wherein an entirety of the sealing member is within the interior of the balloon with the inner member is in the second, proximal position.

13. The method of claim 1, wherein the sealing member comprises an annular valve seal that radially extends from the outer surface of the sealing member, and wherein directing the inner member towards the first, distal position to substantially seal the outlet with the sealing member comprises contacting the annular valve seal against an inner surface of the outlet of the balloon to enhance sealing of the outlet.

14. The method of claim 13, wherein the sealing member further comprises a stop, and wherein directing the inner member towards the first, distal position to substantially seal the outlet with the sealing member comprises limiting the distal movement of the inner member relative to the outlet of the balloon using the stop.

15. The method of claim 14, wherein the outlet of the balloon comprises a valve seal liner, and wherein directing the inner member towards the first, distal position to substantially seal the outlet with the sealing member comprises limiting the distal movement of the inner member relative to the outlet of the balloon via interaction between the valve seal liner and the stop.

16. The method of claim 14, wherein the stop is proximal of the annular valve seal along the sealing member.